Measuring and Reducing Excessive Infant Crying (UTHealth THB)

National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.

Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks. Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant & maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).

Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".

Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).

Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".

Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.

At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.

We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)

Inclusion Criteria: term, singleton neonates otherwise healthy parent must have at least a 6th grade understanding of English or Spanish infant must have colic (greater than 3 hours of crying per day) OR the infant's crying causes excessive stress on the either parent Exclusion Criteria: cannot have a condition which would reasonably impact alertness or behavior